A Clinical Trial in Healthy Volunteers and Volunteers With Recurrent Genital Herpes to Study the Safety, Tolerability, and Immune Responses After Vaccination With an Investigational Vaccine Designed to Prevent Genital Herpes Lesions
← catalyst calendarNCT05432583 · readout ≤ 72 d
Sponsored by BioNTech SE (industry) · BNTX — their whole pipeline →.
Phase
Phase 1
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Triple · Prevention
Enrollment
318actual
Sites
6
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-12-08 | actual | When the study began enrolling |
| Primary completion | Oct 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Oct 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2022-06-27 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-10-20 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Genital Herpes Simplex Type 2
Interventions
- Biological: BNT163
- Other: Placebo
Primary outcomes
what the primary-completion date above is the date OFFrequency of solicited local reactions at the injection site (pain, erythema/redness, induration/swelling) recorded up to 7 days after each dose
measured Up to 7 days after each dose
Frequency of solicited systemic reactions (vomiting, diarrhea, headache, fatigue/tiredness, myalgia, arthralgia, chills, and fever) recorded up to 7 days after each dose
measured Up to 7 days after each dose
Percentage of participants with at least one unsolicited adverse event (AE) occurring up to 28 days after each dose
measured From Day 1 up to Day 197
Percentage of participants in each cohort with at least one serious AE, or AE of special interest, or medically attended AE occurring up to 24 weeks post-Dose 3 (Parts A & B) or post-Dose 2 (Part C)
measured From Day 1 up to Day 337
Number of unsolicited AEs occurring up to 28 days after each dose
measured From Day 1 up to Day 197
Percentage of unsolicited AEs occurring up to 28 days after each dose
measured From Day 1 up to Day 197
Permalink · BNTX's whole pipeline · Catalyst calendar · Every registered study · What changed